Hi there, we see you're using OS, why not try our app?
Download
Skip to main content

Typical plasmid DNA release specifications

Typical plasmid DNA release specifications

Analytical mehtod
Analytical mehtod
Description
Description
Specification
Specification
Appearance
Description
Ph.Eur 2.9.20 Visual inspection
Specification
Clear, colourless and free of visible particles
Fill Volume
Description
Gravimetrically determined
Specification
Conforms
DNA Concentration
Description
Ph.Eur 2.2.25 UV-absorbance at OD 260nm
Specification
Conforms
DNA Purity
Description
Measured using Absorbance ratio at UV 260/280 nm
Specification
Ratio of ≥ 1.8
Identity and integrity
Description
Restriction mapping
Specification
Consistent to reference plasmid DNA pattern
Plasmid DNA Homogeneity
Description
DNA Sequencing
Specification
100% match to reference plasmid DNA sequence
Plasmid DNA Forms
Description
HPLC
Specification
> 80% Supercoiled Form
Residual host cell protein
Description
Micro-BCA assay
Specification
< 3%
Residual host cell RNA
Description
RibogreenTM fluorometric assay
Specification
< 3%
Residual host cell gDNA
Description
Q-PCR
Specification
< 3%
Endotoxin
Description
LAL assay (Ph.Eur 2.6.14)
Specification
< 10 EU/mg of DNA
pH
Description
Ph.Eur 2.2.3 Potentiometric
Specification
Conforms
Osmolality
Description
Ph.Eur 2.2.35
Specification
Conforms
Sterility
Description
Ph.Eur 2.6.1 USP <71>
Specification
Sterile

Typical cell bank release specifications

Analytical method
Analytical method
Description
Description
Specifications
Specifications
Viability
Description
Plating on culture media by dilution studies
Specifications
Report
Purity
Description

Plating on culture media

Absence of bacteriophage
Specifications
None detected
Host cell identity
Description

Phenotype by API 20E test

Genotype by RAPD

Gram Staining
Specifications

Conforms to Host cell line

Gram Negative
Plasmid Retention
Description
Replica plating studies on appropriate culture media
Specifications
>90% antibiotic resistance
Plasmid Integrity
Description
Restriction mapping
Specifications
Consistent to reference plasmid DNA patterns
Plasmid DNA Homogeneity
Description
DNA Sequencing
Specifications
100% match to reference plasmid DNA sequence
Plasmid DNA Yield
Description
HPLC
Specifications
Report result
Plasmid DNA copies per cell
Description
Agarose gel electrophoresis
Specifications
Report result

Get in touch

Call us on:

01934 880 150

07471 147 804

Email us at:

enqcbc@nhsbt.nhs.uk



You may also be interested in